Randomized Clinical Trial on Transanal Irrigation

Randomized Clinical Trial Assessing the Effect of Transanal Irrigation With Cone Catheter Versus Conservative Bowel Management on Symptoms of Low Anterior Resection Syndrome After Rectal Resection

Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care.

The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter.

Design of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy.

The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site.

Primary endpoint and secondary endpoints

Primary endpoint:

• LARS score, obtained from the LARS score questionnaire*

Secondary endpoints:

• Number of subjects with Major LARS*
• FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire*
• FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire*
• FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire*
• FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire*
• EQ-5D-5L - utility score*
• EQ-5D-5L - VAS score (scale 0-10 cm)*
• Satisfaction with treatment (scale 0-10 cm)*
• Number of adverse events* *All endpoints are measured per subject at study termination

Study Overview

• Status: Completed
• Conditions: Low Anterior Resection Syndrome
• Intervention / Treatment: Device: Peristeen cone catheter

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be at least 18 years of age and have full legal Capacity
2. Have given written informed consent
3. Be mental and physical capable to perform transanal irrigation with cone catheter
4. Have a LARS score ≥ 30 after rectal resection
5. Be treated according to individual treatment protocol for conservatory bowel management at participating site
6. Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure
7. At least 3-months from last surgery in colorectum
8. Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure

Exclusion Criteria:

1. Active/recurrent colorectal cancer
2. Leaking anastomosis
3. Known anal or colorectal stenosis
4. Within 4 weeks of endoscopic polypectomy
5. Ischaemic colitis
6. Acute inflammatory bowel disease
7. Acute diverticulitis
8. Current or planned pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peristeen; Subjects to use newly developed Peristeen cone catherter device	Device: Peristeen cone catheter; The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.
No Intervention: Standard of care; subjects continue with their standard of care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LARS score	obtained from the LARS score questionnaire	measured pr subject at study termination after 12 weeks

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Collaborators: MedPass International
• Investigators: Principal Investigator: Guillaume MEURETTE, MD, CHU Nantes, France

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: CP327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No